1. Field of the Invention
The system and method of the invention described herein relates to the enrollment of participants into a data supply chain through configuration and hardlinking or object hyperlinking or transmission of electronically readable identification strings of data, biometric data, matrix or two dimensional codes, and other strings of identification data readable by electronic devices. More specifically, it introduces art to format and configure electronically readable identification data or biometric data or matrix codes that conform to one or a plurality of metadata standards including formatting, configuring, and joining codes or strings of characters to enroll contributors, collectors, auditors, and users of data into a data collection and processing method and system to use for research or risk management or quality control or performance feedback to manufacturers or service providers or individual actors or persons upon sale or distribution or exchange of a product or service; also including transaction fees, payment, and other methods for compensating participants for roles undertaken within the data supply chain. Included within the one or a plurality of forms of electronically readable identification to implement the enrollment process is registration for receipt of notifications, alerts and updates to be transmitted to the enrollee, and assignment of the enrollee to roles and functions within the data supply chain. A further aspect of the invention described herein is allocation of prices and fees for users exercising their roles and rights within a data supply chain. The system and method further includes use of electronic devices to transmit and update data strings of biometric information, matrix codes, data from RFID tags, and electronically readable identification codes within electronic devices as information associated with an enrollee or a product or service or a person providing a service changes.
2. Description of the Related Art
Adverse side effects of medications and product defects in manufactured biological and chemical agents or medical or protective devices and equipment can result in harm or loss. Indeed, many products or services may pose a risk to users, purchasers or recipients. Product recalls of automobiles, food, toys, and medicines that were thought to be safe occur with regularity. Gaps in time between trends in data indicating risk and analysis and action regarding said risk can result in unnecessary loss of lives and property. Implementing a rapid enrollment system and method to facilitate input into datasets to be used for data analysis or to trigger notifications and feedback to manufacturers, providers, users, regulators, and other vested parties will enable early warning of emergent problems and rapid response to risks associated with a product or service. Notifications, alerts, and other communications enabled through the system and method of the invention described herein distributed to participants in a data supply chain including regulatory agencies, manufacturers, service providers, and individual end users of products and services will enable better management of risks and liabilities in real time. Monetizing the enrollment event may motivate participation in a data supply chain. Additionally, assigning values and prices and other rewards to rights and roles assigned participants in a data supply chain through the enrollment process structures and rationalizes widely distributed yet flexible participation.
The Department of Homeland Security and the FDA are encouraging development of systems and methods for real time tracking of the distribution, utilization, and positive or adverse impacts of biological and chemical agents or equipment that may be distributed through emergency response channels or through standard retail and other distribution channels and outlets during emergency events. Enrolling users of products and services into feedback processes, especially feedback processes for vaccines pharmaceuticals or medical devices, will support statutory and regulatory requirements to track risks and other data or information following regulatory approval and upon inclusion into distribution networks. Studies of long term effects and interactions of medications or services, such as medical procedures, also may uncover unanticipated adverse effects.
The invention described herein has a preferred embodiment that includes formatting a QR Code or any of the many variants of matrix codes or other identification codes, including biometric identification, to associate a product or service or procedure with an end user or customer. Upon transfer or implementation or purchase or initiation of use of a product or service or procedure, a link between said end user or customer and other participating entities in a data supply chain can be established. For example, the recipient of the product as well as the vendor and provider can enroll to access data collection protocols as data contributors or to serve other roles within a data supply chain.
The term “data supply chain” is intended to describe a linked system of data contributors, protocols and formats for collection of data, data from automated entry and posting processes, input from persons that vet audit and analyze data, triggers and other processes and calculations that mark achievement of positive or negative thresholds of values within the dataset, server or electronic device and human actions resulting from trigger thresholds being reached or surpassed, communications notifications or additional server or electronic device actions involving or forwarded to contributors and other participants, and other forward or backward chains of server or electronic device actions that may be initiated by achievement of trigger conditions including allocation of transaction fees prices awards charges and other exchanges of social or physical currencies among participants in the data supply chain and process. The value of a right or a role within a data supply chain may vary. Users who contribute observations or data may be allocated a payment per contribution; while those who review or audit observations may be allocated a different level of payment or reward. In contrast, users who access a portion of a data supply chain may be charged or fee for the right to view or download or access or may be assigned a right to receive a notification or other action resulting from the operation of the data supply chain. The allocation of payments or charges will vary according to the value propositions and decisions of managers of the data supply chain regarding rights and roles for interaction with said data supply chain.
An additional use of electronically readable identification strings or biometric data or matrix codes in the invention described herein is the optimal assignment to a potential enrollee of an electronically readable identification string such as a string of biometric data and a matrix code or an RFID tag that includes identity data and other forms of identifying data thus enabling enrollment data to be enriched. Enrollment of contributors may be automated through use of said electronically readable identification strings or biometric data or matrix codes or RFID tags when transmitted or exchanged by electronic devices. Enrollment of service providers or product manufacturers into a data supply chain may also be achieved through use of electronically readable identification strings or matrix codes from said providers or product manufacturers. A further use of data strings or matrix codes includes assignment of a data string or matrix code to associate with each product or service or procedure the service provider or manufacturer elects to link into the data supply chain, thus registering said product or service or procedure or a variant of said product or service or procedure. Thus, there are six kinds of participation within a data supply chain; first, the producer or manufacturer or provider of the product or service or procedure that is to be associated with observations; second, the product or service or procedure or even the person or employee that is the target or recipient of observations; third, the persons or devices that generate and input observations about the target or recipient of the observations; fourth, the persons or equipment that vet or validate observations for processing and other actions, such as routing notifications and reports regarding the observations to any of the entities participating in the data supply chain; fifth, the regulatory or financial processing entity that may not be in a direct relationship with the targets of observations, but may be enabled to interact with the datasets within the data supply chain and be included in notification and reporting in order to do external reviews or to allocate and implement payment or exchange of fees prices and other rewards to other participants; and sixth, where the participants does not participate in improving or changing the content of the data supply chain, yet may view or review or download data or be the recipient of server actions generated by changes within the data supply chain.
Electronically readable identification within RFID tags, embedded chips, and two dimensional matrix codes can carry significantly more data than earlier constructs for code strings, such as UPC codes; and are now capable of including data from an enrollee's medical history, biometric data, and financial and transactional information for posting to one or a plurality of datasets on a server or device homing the enrollee's enrollment information. Electronic devices capable of capturing biometric data may also post or append said data to an enrollee's enrollment or registration information.
Structuring automated enrollment and payment or incentives for real time end user input into a disciplined research process included within a well designed data supply chain will advance the public interest. The invention described herein can further be folded into any of the processes for offering reviews and feedback through social networks and through direct registration or subscription to feedback formats and processes on websites managed by manufacturers or producers as well as by software as a service (SaaS) vendors. The invention described herein can further be applied to risks associated with behavior of persons operating as representatives of agencies or organizations in a fashion similar to application of the invention to capturing data regarding impact or consequences resulting from use of a service or product.
Art to implement data supply chain and provide incentives to participate in data supply has been evolving. The invention described herein advances the advantages of the data supply chain with triggered real time notifications introduced by Smith (U.S. Pat. No. 7,860,760). That system and method, Smith (U.S. Pat. No. 7,860,760), enables pricing of notifications and server actions triggered by new or updated data streamed or posted into a dataset. Art introduced through Smith (Ser. No. 12/930,280) enables pricing of a data item for inclusion into a data supply chain by its popularity as a search terra Smith (Ser. No. 12/932,798) of which this invention is a Continuation in Part also teaches art to weight and price contributions from variably weighted sources and variably weighted observations of research targets or data items. Additional art introduced by Smith (Ser. No. 12/932,797) describes a system and method for calculating fees for interaction of a user with a graphical user interface (GUI) on a website or host server housing a dataset or a plurality of datasets accessible through said GUI. The invention described herein enables enrolled participants to interact with GUI's as described by Smith (Ser. No. 12,932,797) if the data collector or enrolled data contributor opt to engage in the pricing and fee exchanges of that system and method. Further art introduced by Smith (Ser. No. 13/134,596) offers a system and method to facilitate and price data exchange from electronic devices linked to the systems and methods of Smith (U.S. Pat No. 7,860,760, Ser. Nos. 12/932,797, and 12/932,798). Art has also been described, Smith to integrate fees and rewards for incremental improvements, updates, and additions of data to data accumulation processes within Social Networks or networks of users and servers or websites. Smith (Ser. No. 13/136,421) further introduces a system and method for pricing linking of message streams and RFID tags and UPC codes to data sources. That invention, Smith (Ser. No. 13/136,421), deals with pricing uploading of data and data streams through electronic devices, rather than enrollment of participants into a data supply chain. The invention described herein takes a different approach to pricing and inclusion by addressing pricing and fees for enrollment registration or subscription and prices and fees for variants of roles and rights assigned to participants in a data supply chain.
While each of the systems and methods of the systems, and methods of the patent and patent applications cited herein can be implemented completely independently of one another, an integration of all said cited systems and methods will facilitate the social objective of encouraging the evolution of real time data supply chains to reduce risks and leverage knowledge and information. The art described in the invention herein provides a method and system for rapid enrollment of participants into a data supply chain. At every point within a data supply chain, transaction fees and prices can be implemented and established for enrolling and registering data contributors.
Clinical Research Organizations (CRO's) and other research service providers enroll contributors of data and feedback into research processes and programs that include access to formal protocols. For example, CRO's enlist interviewers or agents to collect data from physicians who are in a position to observe risks or side effects; or CRO's provide survey forms (often called “protocols”) and materials for physicians or other health care providers to complete regarding observations of side effects and drug interactions and medical outcomes. Often, responses to questions on survey forms are manually entered into datasets by data entry technicians or entered through electronic devices implementing survey form reading software, introducing a potential for data entry errors. Additionally, when CRO's conduct telephone surveys and use other forms of personal contact such as office visits and interviews to actively collect data from users of pharmaceuticals or other products, the agents or equipment collecting the information may misinterpret or inaccurately record the information. The system and method of the invention for rapid enrollment of contributors to research protocols described herein reduces the lag time between end users of products and services initiating use of a product or service and the registering and posting observations of side effects or responses to a pharmaceutical or medication, increasing the potential for timely accurate structured data entry. Broadly distributed enrollment of contributors into a data supply chain can also supplement, enhance, and serve to check or verify the quality of data obtained through personal interaction and interviews, especially if control or comparison groups are part of follow on study processes for long term outcomes, for side effects, and for unanticipated adverse impact.
Another common method for collecting data is to email a link to the website housing a survey to a potential contributor. Manufacturers and service providers often retain SaaS vendors that offer email linking and other survey research capabilities. Companies and services such as SurveyMonkey or Zoomerang enable researchers to construct and deliver surveys and link contributors into survey administration processes. Research and survey organizations like Gallup and Gartner also structure temporary or permanent links between their sites and distributed groups of contributors to collect input into survey research forms. Data collected through these survey research organizations is analyzed at intervals; sometimes even regular intervals. However, the delay between input and analysis and notification of persons or entities that might be subject to risks or liabilities can be costly. The system and method described herein integrates communication and notification methods upon enrollment to reduce the lag time between discovery of risk and alerting enrollees and other parties included into the data supply chain.
An industry has evolved to enable the processing and interpretation of data gathered through survey collection tools. Art introduced by Smith (U.S. Pat. No. 7,860,760) enables the bypassing of much of the data processing required in survey research and moves directly to triggered actions based upon thresholds or triggers set by researchers or physicians or others engaged in risk management as data is accumulated in real time. Post hoc analysis of the collected data is still available, but the delay between input related to known risks or risk thresholds and initiation of alerts is eliminated. Art introduced by Smith (Ser. No. 12/932,798) enables the weighting of input sources and the weighting of targets for observation and can be integrated with the art of Smith (U.S. Pat. No. 7,860,760) to improve relevance, timeliness and utility of data collected. The invention described herein is a Continuation in Part of Smith (Ser. No. 12/932,798). If contributors of data enter responses and observations into protocols that are sufficiently well formed and constructed, and are enabled to offer sufficient detail or context regarding;                the behavior and impact of a person providing a service,        the consequences or side effects of use of a product or performance of a procedure,        the consequences or results that emerge following the provision of a service or use of a product,        and consequences or results that follow the implementation of a process or procedure,the quality and utility and appropriateness of the data and the resulting response to analysis and interpretation may be enriched.        
Eliminating the complexities of enrollment of contributors and other participants and bypassing the multiple steps and processes required for analysis prior to action enables risk management to be more efficiently and effectively managed on a larger scale and can leverage the art in Smith (U.S. Pat. No. 7,860,760) without sacrificing the quality of the data collected. However, without social and monetary incentives to encourage enrollment, or without monetization of the enrollment transaction as introduced by the system and method of the invention described herein, the volume of real time collection of observations from widely dispersed sets of enrollees in real time is likely to be lower, resulting in slower accumulation of data that might trip a risk and notification trigger or threshold. The combination of a simple enrollment process with rewards and incentives and monetization of the process for enrollment will facilitate a robust and continuous supply of actionable real time data. Conversely, providing access to portions of a data supply chain or actions generated through a data supply chain enables fees and payments to be charged to those who benefit from the data supplied or accessed.
The emergence and wide distribution of smart phones and other electronic devices capable of implementing computer readable code expands the technological capacity to include end users of products and services into rigorous research processes efficiently and automatically. In the event of national regional or local emergencies, these electronic devices can enable tracking the distribution, utilization, and impact of resources or assets. Further, it can enable receipt of continuous feedback from emergency responders or citizens in possession of said resources or assets to improve decision making regarding levels of risk, prioritizing allocation of resources, and other factors. Enrolling both emergency responders and citizens rapidly and efficiently into real time contributions of data to datasets of value to governmental or regulatory agencies and other stakeholders or entities for the regulation, management, or reduction of risks to public health or welfare is essential, for managing emergency and crisis situations. Linking the user of the resource, the provider of the resource, ad hoc or pre-validated research protocols, and real time triggering of alerts and notifications can enable truly flexible real time responses to emergency situations.
Users and producers of data in the various forms of databases, data tables, streams of data from RFID tags, data generated by and through messaging services and social networking sites, and data generated by the multitude of electronic devices capable of implementing computer readable code will benefit from improved and additional tools for enrolling voluntary contributors of data into a data supply chain. The invention described herein addresses a system and method for achievement of a subset of a data supply chain we have labeled C1 in the group of four fundamental components of a data supply chain we label as “Delta4C:”                1. C1=Connect and enroll all involved parties or participants rapidly and effectively from a distributed network to properly include and assign observers into a process for data contribution        2. C2=Collect real time observations from a full circle of contributors with variable weighting for reputation and access to relevant information        3. C3=Compute the values and ratings of accumulated observations to assess whether thresholds for risks or alerts have been met or surpassed        4. C4=Communicate or notify the right parties regarding information that is actionable for them.        
The method and system of the invention described herein focuses won the term labeled “C1” in the list and enables rapid enrollment of end users of products or goods and services as contributors of real time actionable intelligence and information to be used to reduce risks in times of national emergency as well as collect routine incremental observations. The method and system will also enable implementation of transaction fees and charges to be paid to the provider or vendor doing the enrollment and also enable the producer of the product or service to implement rewards, fees, bounties, coupons, and other incentives for contributions of data to a data supply chain. Using the system and method, FDA, CDC, HSA, FEMA, DOD and other agencies or entities may accumulate input from dispersed contributors; including observations of the utility, effects, impacts, outcomes, side effects, associated risks, advantages, quality or other measures, and numerical ratings useful for assessing a manufactured item or service or process. Indeed, the system and method can be applied to any subject or topic for research, such as biological or social or environmental interactions. The system and method of the enrollment process may be enriched to include sufficient information about enrollees to enable real time notifications and communications to be tailored to inform and instruct enrollees and emergency responders of actions to undertake in response to emergent or unique situations.
The FDA has begun to consider tools and mechanisms for a “flexible, nimble system to produce medical countermeasures rapidly in the face of any attack or threat, known or unknown,” and the rapid enrollment of contributors to the data supply chain of observations regarding risks and liabilities along with the notification processes will facilitate achievement of that objective. The data supply chain and accompanying infrastructure will enable the goal of the FDA's MCMi regulatory science program (Pillar II): “to facilitate, simplify, and speed the development and evaluation of medical countermeasures by . . . risk communication to improve public health outcomes, . . . and real-time tracking and evaluation of MCM safety and efficacy during public health emergencies.” There are significant benefits to meliorating risks through capturing real time observations from a full circle of observers and to proactively notify providers, patients or other recipients of services or products, as well as manufacturers and service providers as risks are identified. Easing processes to enable every responsible party and every user of a medication or medical device or product or service to contribute weighted, vetted, context rich data regarding side effects, drug interactions, contamination, manufacturing defects, or other potential concerns before they endanger larger groups of consumers or escalate into liabilities will make consumers safer and provide emergency responders with actionable intelligence as they formulate policy and determine courses of action. The richer the information regarding the contributor of data, such as the contributor's medical history or genetic map or demographic information, the more comprehensive the analysis and interpretation of the interaction of the contributor and the product or service. Conversely, the richer the information regarding the product or service itself and the provider of the product or service, the more comprehensive the analysis and interpretation of the interactions between persons performing a service or between products or services and those who receive the services or products. Generating and assigning matrix or other codes or biometric data to potential participants in a data supply chain can leverage any of the information the enrollee chooses to contribute or make available to the research process as well as facilitate the automation of registration or subscription, assignment and transfer of payments and fees and other incentives, and assignment of the enrollee to the proper subset of systems and processes and research protocols within a data supply chain.